ISO 15378 2017 Primary packaging materials for medicinal products - Lead Implementer Course

Description

ISO 15378:2017 primary packaging materials for medicinal products identifies good manufacturing practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry. An effective implementation is essential if organizations are to maximize the cost saving, performance, and customer satisfaction benefits of ISO 15378 2017 standards. ISO 15378 2017 lead implementer course is good for those who need an overview on the ISO 15378 2017 standards, or those who will be involved in the implementation of ISO 15378 2017 standards within an organization. ISO 15378 2017 implementation course will guide you through the implementation process by explaining the requirements of ISO 15378 2017 standard and how they can be applied using international best practices and methods. Using a step-by-step approach, you will learn how to develop an implementation plan, create the necessary documentation, monitor the quality management system, and achieve continual system and quality improvement.

Who Should Attend?

• Anyone responsible for implementing ISO 15378 2017 standard
• Those who want to learn how to interpret the requirements of ISO 15378 2017 standard
• Managers or executives involved in delivering ISO 15378 2017 standard
• Heads of various departments in an organisation
• Those who are planning for a career or working in a quality and performance oriented organisation
• Anyone looking to gain skills and knowledge to improve their career performance 

Key Benefits

• Understand concepts and importance of the ISO 15378 2017 management system principles.
• Grasp the application of risk-based thinking, leadership and process management
• Interpret requirements of ISO 15378 2017 standard and its effective application for managing and improving the functioning of an organization through process approach. 
• Understand and develop skills for implementation of management system to manage processes of the organization.
• Build stakeholder confidence by managing processes in line with the latest requirements
• Understand and develop problem solving skills 
• Maintain and continually improve your quality management system
• Learn techniques to create and manage documents and records relevant to ISO 15378 2017 quality management system , critical to the products and services delivered and those required to meet customer and regulatory requirements
• Learn skills in human resource management, supplier management, customer management , operations management, inventory management, laboratory management, production planning and logistics management
• Learn to identify and mitigate internal and external issues relevant to businesses
• Learn to identify stakeholder expectations and prepare action plans to fulfill them
• Learn to define and optimize the processes in your organisation
• Understand the methods to develop a customer focus approach in an organisation
• Identify improvement objectives and plans to achieve them
• Understand traceability requirements relevant to products and services 
• Develop an effective business communication plan 
• Learn to manage design and development activities
• Learn techniques to manage nonconformity in products and services delivered and take corrective actions 
• Learn to implement the communication requirements 
• Learn to develop and assign roles and responsibilities to implement and follow ISO 15378 2017 standard
• Learn to implement  the documentation and record keeping practices for ISO 15378 2017 standard
• Learn to implement the inspection and verification techniques to ensure compliance to the requirements of ISO 15378 2017 standard
• Fill gaps in your professional knowledge
• Learn to implement the GMP requirements for printed primary packaging materials

Learning & Evaluation Method

This is  a live and interactive course.  Once you purchase the course, our team will contact you to plan the training. No matter where you are located, we schedule the classes based on your convenience and time zone. You can plan to attend the training in sessions of 4 or 8 hr duration, based on how much time you can spend in a day.

Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.